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Limited coverage criteria – cladribine

Last updated on March 17, 2025

 

Return to Special Authority drug list 

Generic name

cladribine

Strength & form

10 mg tablet

Special Authority criteria

Approval period

As second-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) that is diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence

This drug is for the treatment of patients 18 years of age and older who meet all of the following criteria:

Initial treatment course (1.75 mg/kg per year)

  • For use in patients who have had an inadequate response to, or are unable to tolerate, one previous therapy for RRMS
    AND
  • Who have had at least one relapse within the previous 12 months
    AND
  • Special Authority request is submitted by a neurologist from a designated MS clinic3

1 treatment course1,2

Second treatment course (1.75 mg/kg per year)

  • Patient has received the initial treatment course
    AND
  • Special Authority request is submitted by a neurologist from a designated MS clinic3

1 treatment course1,2

Practitioner exemptions

  • None

Special notes

  1. Treatment course of 1.75 mg/kg body weight per year taken over 2 weeks, for two years (cumulative dose of 3.5 mg/kg body weight over 2 years)
  2. PharmaCare coverage is limited to two courses of treatment per lifetime
  3. The patient is under the care of a specialist who has experience in the diagnosis and management of RRMS

Special Authority request form(s)